Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2017-05-16
2019-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Treatment Arm
Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
Normal Saline 5mL
Control arm subjects will receive Normal Saline 5 mL IV over 1 hour
Prochlorperazine 0.15 mg/kg up to 10 mg IV
Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Diphenhydramine 1 mg/kg up to 50 mg IV
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Study Arm
Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
Normal Saline 20mL/kg
Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,
Prochlorperazine 0.15 mg/kg up to 10 mg IV
Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Diphenhydramine 1 mg/kg up to 50 mg IV
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Interventions
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Normal Saline 5mL
Control arm subjects will receive Normal Saline 5 mL IV over 1 hour
Normal Saline 20mL/kg
Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,
Prochlorperazine 0.15 mg/kg up to 10 mg IV
Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Diphenhydramine 1 mg/kg up to 50 mg IV
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Temperature less than 100.4 F
3. Normal neurologic exam and normal mental status
Exclusion Criteria
2. Meningeal signs are present
3. Acute angle closure glaucoma is suspected
4. Head trauma within the previous two weeks
5. Lumbar puncture within the previous two weeks
6. Thunderclap onset of the headache
7. Known allergy to one of the study drugs
8. History of intracranial hypertension
9. Is a prisoner
10. Patient declined informed consent
11. Non-English speaking patient or parent/guardian for pediatric patients
12. Attending provider excludes patient
13. Severe Dehydration
10 Years
65 Years
ALL
No
Sponsors
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University Medical Center of Southern Nevada
OTHER
Responsible Party
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Joseph (Tony) Zitek, MD
MD
Principal Investigators
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Tony Zitek, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center of Southern Nevada
Locations
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University medical Center of Southern Nevada
Las Vegas, Nevada, United States
Countries
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References
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Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
Friedman BW, West J, Vinson DR, Minen MT, Restivo A, Gallagher EJ. Current management of migraine in US emergency departments: an analysis of the National Hospital Ambulatory Medical Care Survey. Cephalalgia. 2015 Apr;35(4):301-9. doi: 10.1177/0333102414539055. Epub 2014 Jun 19.
Balbin JE, Nerenberg R, Baratloo A, Friedman BW. Intravenous fluids for migraine: a post hoc analysis of clinical trial data. Am J Emerg Med. 2016 Apr;34(4):713-6. doi: 10.1016/j.ajem.2015.12.080. Epub 2015 Dec 30.
Cicek M, Karcioglu O, Parlak I, Ozturk V, Duman O, Serinken M, Guryay M. Prospective, randomised, double blind, controlled comparison of metoclopramide and pethidine in the emergency treatment of acute primary vascular and tension type headache episodes. Emerg Med J. 2004 May;21(3):323-6. doi: 10.1136/emj.2002.000356.
Friedman BW, Adewunmi V, Campbell C, Solorzano C, Esses D, Bijur PE, Gallagher EJ. A randomized trial of intravenous ketorolac versus intravenous metoclopramide plus diphenhydramine for tension-type and all nonmigraine, noncluster recurrent headaches. Ann Emerg Med. 2013 Oct;62(4):311-318.e4. doi: 10.1016/j.annemergmed.2013.03.017. Epub 2013 Apr 6.
Kostic MA, Gutierrez FJ, Rieg TS, Moore TS, Gendron RT. A prospective, randomized trial of intravenous prochlorperazine versus subcutaneous sumatriptan in acute migraine therapy in the emergency department. Ann Emerg Med. 2010 Jul;56(1):1-6. doi: 10.1016/j.annemergmed.2009.11.020. Epub 2010 Jan 4.
Tanen DA, Miller S, French T, Riffenburgh RH. Intravenous sodium valproate versus prochlorperazine for the emergency department treatment of acute migraine headaches: a prospective, randomized, double-blind trial. Ann Emerg Med. 2003 Jun;41(6):847-53. doi: 10.1067/mem.2003.195.
Jones J, Sklar D, Dougherty J, White W. Randomized double-blind trial of intravenous prochlorperazine for the treatment of acute headache. JAMA. 1989 Feb 24;261(8):1174-6.
Friedman BW, Esses D, Solorzano C, Dua N, Greenwald P, Radulescu R, Chang E, Hochberg M, Campbell C, Aghera A, Valentin T, Paternoster J, Bijur P, Lipton RB, Gallagher EJ. A randomized controlled trial of prochlorperazine versus metoclopramide for treatment of acute migraine. Ann Emerg Med. 2008 Oct;52(4):399-406. doi: 10.1016/j.annemergmed.2007.09.027. Epub 2007 Nov 19.
Callan JE, Kostic MA, Bachrach EA, Rieg TS. Prochlorperazine vs. promethazine for headache treatment in the emergency department: a randomized controlled trial. J Emerg Med. 2008 Oct;35(3):247-53. doi: 10.1016/j.jemermed.2007.09.047. Epub 2008 Jun 5.
Coppola M, Yealy DM, Leibold RA. Randomized, placebo-controlled evaluation of prochlorperazine versus metoclopramide for emergency department treatment of migraine headache. Ann Emerg Med. 1995 Nov;26(5):541-6. doi: 10.1016/s0196-0644(95)70001-3.
Miner JR, Fish SJ, Smith SW, Biros MH. Droperidol vs. prochlorperazine for benign headaches in the emergency department. Acad Emerg Med. 2001 Sep;8(9):873-9. doi: 10.1111/j.1553-2712.2001.tb01147.x.
Dychter SS, Gold DA, Carson D, Haller M. Intravenous therapy: a review of complications and economic considerations of peripheral access. J Infus Nurs. 2012 Mar-Apr;35(2):84-91. doi: 10.1097/NAN.0b013e31824237ce.
Homer LD, Holmes KR. Risks associated with 72- and 96-hour peripheral intravenous catheter dwell times. J Intraven Nurs. 1998 Sep-Oct;21(5):301-5.
Gentges J, Arthur A, Stamile T, Figureido M. Peripheral Intravenous Line Placement and Utilization in an Academic Emergency Department. J Emerg Med. 2016 Feb;50(2):235-8. doi: 10.1016/j.jemermed.2015.08.006.
Myburgh JA. Fluid resuscitation in acute medicine: what is the current situation? J Intern Med. 2015 Jan;277(1):58-68. doi: 10.1111/joim.12326. Epub 2014 Nov 25.
Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.
Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.
Patniyot IR, Gelfand AA. Acute Treatment Therapies for Pediatric Migraine: A Qualitative Systematic Review. Headache. 2016 Jan;56(1):49-70. doi: 10.1111/head.12746.
Richer L, Craig W, Rowe B. Randomized controlled trial of treatment expectation and intravenous fluid in pediatric migraine. Headache. 2014 Oct;54(9):1496-505. doi: 10.1111/head.12443. Epub 2014 Aug 28.
Zitek T, Sigal T, Sun G, Martin Manuel C, Tran K. I-FiBH trial: intravenous fluids in benign headaches-a randomised, single-blinded clinical trial. Emerg Med J. 2020 Aug;37(8):469-473. doi: 10.1136/emermed-2019-209389. Epub 2020 Jul 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-54
Identifier Type: -
Identifier Source: org_study_id
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